The Food and Drug Administration (FDA) on Oct. 29 expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include children ages 5 through 11.
Like those ages 12 and older, children will receive the vaccine in a primary series of two doses three weeks apart. However, their doses are smaller — 10 micrograms compared with the 30 microgram dose for adults.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will meet Nov. 2, from 10 am to 5 pm ET, to discuss further clinical recommendations for vaccinating children.
CDC also developed planning resources for vaccinating children, including:
- a pediatric COVID-19 operational planning guide for jurisdictions;
- tips for health care providers on talking to parents about vaccination;
- information about the federal retail pharmacy program for COVID-19 vaccination; and
- resources for parents and caregivers.
FDA Delays Approval of Moderna Vaccine for Adolescents
Meanwhile, FDA on Oct. 31 informed Moderna that the agency will require more time to evaluate the company’s EUA request for the use of its vaccine in adolescents ages 12 to 17, citing reports of myocarditis, or inflammation of the heart muscle. Moderna will delay its application for use in the pediatric population until FDA completes its review of the adolescent request, which could take until January 2022.
CDC Call on Booster Shot Recommendations
CDC on Oct. 26 held a Clinician Outreach and Communication Activity (COCA) call with an overview of the latest recommendations for administering COVID-19 booster vaccines. This call, available on-demand, also included information about early safety monitoring for additional COVID-19 vaccine doses.
FDA Import Alert on Medical Gloves
In an Oct. 29 announcement FDA recommends health care facilities and providers not purchase or use imported medical gloves from certain companies that appear to be in violation of the agency’s laws and regulations, thus creating risk for patients and users. FDA encourages reporting any medical gloves that appear to be soiled or otherwise fraudulent to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.